LEVOX 750/MG FC TAB 5/FC TAB

Indications

Approved Uses

Nosocomial pneumonia, Community-acquired pneumonia, Acute bacterial rhinosinusitis, Acute bacterial exacerbation of chronic bronchitis, Chronic bacterial prostatitis, Complicated skin and skin structure infections, Uncomplicated skin and skin structure infections, Complicated urinary tract infections, Uncomplicated urinary tract infections, Acute pyelonephritis, Inhalational anthrax (post-exposure), Plague.

Dosage & Administration

Dosing by Condition

Community-acquired pneumonia: 500mg once daily for 7-14 days or 750mg once daily for 5 days. Nosocomial pneumonia: 750mg once daily for 7-14 days. Acute bacterial sinusitis: 750mg once daily for 5 days or 500mg once daily for 10-14 days. Complicated UTI/pyelonephritis: 750mg once daily for 5 days or 250mg once daily for 10 days. Uncomplicated UTI: 250mg once daily for 3 days. Complicated skin infections: 750mg once daily for 7-14 days. Uncomplicated skin infections: 500mg once daily for 7-10 days. Inhalational anthrax: 500mg once daily for 60 days

Initial Dose

750mg for most common indications like pneumonia and complicated skin infections.

Maintenance Dose

250mg to 750mg once daily depending on indication and severity

Maximum Dose

750mg per day for most indications.

Children's Dosage

Not routinely recommended for children; if used for specific indications (e.g., inhalational anthrax post-exposure, plague), dosing is weight-based per specialist/protocol.

Dose Adjustment Notes

Dose adjustment is required in renal impairment (commonly when CrCl <50 mL/min); no adjustment is generally needed in hepatic impairment; avoid coadministration with antacids/iron/zinc/sucralfate-separate by ≥2 hours.

How to Take

Swallow the 750 mg film‑coated tablet whole with water; may be taken with or without food; take once daily at the same time each day; separate from polyvalent cations (Al/Mg antacids, sucralfate, iron, zinc, calcium/multivitamins) by at least 2 hours before or 2 hours after; maintain adequate hydration.

Side Effects

Common Side Effects

Nausea, diarrhea, headache, dizziness, insomnia (and other common GI effects such as abdominal pain/dyspepsia may occur).

Side Effect Frequency

Common (1-10%): nausea, diarrhea, headache, insomnia, constipation, dizziness, vomiting, abdominal pain, dyspepsia, rash. Uncommon (<1%): tendinitis, tendon rupture, peripheral neuropathy, QT prolongation, hypoglycemia, hyperglycemia, seizures, psychosis, photosensitivity, anaphylaxis, hepatotoxicity, Clostridioides difficile colitis

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to levofloxacin/other quinolones; additionally, avoid use in patients with myasthenia gravis (strong warning/avoidance rather than a universal absolute contraindication in all jurisdictions).

Warnings & Precautions

Warnings/precautions: reserve use when alternatives exist due to disabling adverse reactions; tendon rupture risk (↑ with age >60, steroids, transplant); peripheral neuropathy (stop if symptoms); CNS effects/seizure risk; QT prolongation risk (electrolyte abnormalities, QT drugs); dysglycemia (monitor diabetics); C. difficile diarrhea; photosensitivity; aortic aneurysm/dissection risk (avoid/caution in at-risk patients); avoid in myasthenia gravis.

Age Restriction

Adults (≥18 years). Pediatric use is generally not recommended; may be used only for specific indications (e.g., inhalational anthrax post-exposure, plague) when benefits outweigh risks and under specialist supervision.

Driving Warning

Not safe. Levofloxacin may cause dizziness, lightheadedness, tremors, and other CNS effects that could impair driving ability. Patients should be cautious about driving or operating machinery until effects are known.

Drug Interactions

Drug Interactions

Key interactions: polyvalent cations (Al/Mg antacids, iron, zinc) and sucralfate (↓ absorption-separate dosing); warfarin (↑ INR/bleeding risk); antidiabetic agents/insulin (dysglycemia); QT-prolonging drugs (additive QT risk); corticosteroids (↑ tendon rupture risk); NSAIDs (↑ CNS stimulation/seizure risk); didanosine buffered products (↓ absorption).

Interaction Severity

MAJOR: QT‑prolonging drugs (e.g., amiodarone, sotalol, some antipsychotics) due to torsades risk; corticosteroids (especially in older adults/transplant) increase tendinopathy/rupture risk. MODERATE: Warfarin (↑INR/bleeding-monitor), antidiabetic agents (dysglycemia), NSAIDs (↑CNS stimulation/seizure risk), theophylline (CNS stimulation/level effects-monitor). MINOR/CLINICALLY IMPORTANT: polyvalent cations/sucralfate/iron/zinc/calcium reduce absorption-separate dosing.

Food Interaction

Can be taken with or without food (no specific meal timing restriction for the film‑coated tablet).

Special Populations

Children

Not routinely recommended for children; if used for specific indications (e.g., inhalational anthrax post-exposure, plague), dosing is weight-based per specialist/protocol.

Elderly

Standard adult dosing, but adjust for renal function as elderly patients are more likely to have decreased renal function. Use with caution due to increased risk of tendon disorders and QT prolongation.

Kidney Impairment

For 750 mg regimen: CrCl 20-49 mL/min: 750 mg initial dose, then 750 mg every 48 h; CrCl 10-19 mL/min (and HD/CAPD): 750 mg initial dose, then 500 mg every 48 h.

Storage & Patient Advice

Stopping the Medicine

Complete the prescribed course unless serious adverse effects occur; stop levofloxacin immediately and seek urgent medical advice for tendon pain/swelling, neuropathy symptoms, severe CNS effects, or allergic reaction.

Patient Counseling

Complete the full prescribed course; take once daily at the same time; swallow whole with water and stay hydrated; separate from antacids/iron/zinc/calcium/sucralfate by ≥2 hours; avoid excessive sun/UV and use protection; stop and seek care for tendon pain/swelling, new numbness/tingling/weakness, severe/persistent diarrhea, rash/allergic reaction, or palpitations/syncope; diabetics should monitor glucose; use caution driving if dizzy/confused; inform clinician if pregnant/breastfeeding or if you have QT risk factors.

Monitoring Requirements

Monitor renal function (and adjust dose if impaired); monitor for tendinopathy/tendon rupture and peripheral neuropathy; monitor blood glucose in diabetics; consider ECG/QT monitoring in patients with QT risk factors or on QT‑prolonging drugs; for prolonged therapy, periodic CBC and hepatic/renal labs are reasonable.

Pharmacology

Mechanism of Action

Inhibits bacterial DNA gyrase and topoisomerase IV, which are essential enzymes for DNA replication, transcription, repair, and recombination, leading to inhibition of bacterial cell division and cell death.

Duration of Effect

Approximately 24 hours (supports once‑daily dosing).

Half-Life

Approximately 6-8 hours in adults with normal renal function.

Bioavailability

>99%.

Metabolism

Minimal hepatic metabolism; largely excreted unchanged.

Excretion

Primarily renal; about 87% is excreted unchanged in urine (within ~48 hours).

Protein Binding

24% to 38%

Product Information

Available Dosage Forms

For this SFDA-registered product (LEVOX 750 mg): film‑coated tablet for oral use (blister pack of 5).

Composition per Dose

Each film-coated tablet: 750mg levofloxacin

Generic Availability

Yes

Spectrum

Broad

Antibiotic Class

Fluoroquinolone

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